Impella RP with SmartAssist — Class I medical device recall Z-0829-2025
Ongoing recall by Abiomed, Inc., reported 2025-01-22, distributed nationwide. Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting i
| Recall number | Z-0829-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abiomed, Inc., Danvers, MA, United States |
| Recall initiated | 2024-12-12 |
| Classified | 2025-01-15 |
| Reported by FDA | 2025-01-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 1,560 units |
| UPC / GTIN / UDI-DI | 00813502011869 |
| Serial numbers | 394640, 394641, 394643, 394644, 394645, 394646, 394649, 397113, 399628, 401079, 401083, 401559, 401560, 401561, 401563, 401564, 401566, 401753, 401754, 401755, 401756, 401757, 401758, 401759, 401760 and 475 more |
Product
Impella RP with SmartAssist; Product Number: 0046-0035;
Reason for recall
Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Venous (CV) Placement Signal, Pulmonary Artery (PA) Placement Signal & Pulmonary Artery Pulse Index (PAPi) metrics. Abiomed is reinforcing that there is a risk of potential interaction between the tip of guidewires, indwelling central venous lines or devices and inlet of the Impella pumps listed above during the insertion, manipulation, and removal of those devices. The interaction may result in optical sensor damage, temporary pump stop, or permanent pump stop.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0829-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.